FDA 510(k) clearance · back to tracker

HardyDisk AST Tebipenem 10µg (TBP10)

Hardy Diagnostics cleared K262113 on 2026-08-20, decision: substantially equivalent

K-number

K262113

Sponsor

Hardy Diagnostics

Device

HardyDisk AST Tebipenem 10µg (TBP10)

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-08-20

Product code

JTN

Advisory committee

Microbiology

Medical specialty

Microbiology

Regulation number

866.1620

Official FDA record

Open K262113on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.